Abstract

PROCESS VALIDATION AND EVALUATION OF ZIDOVUDINE USING QBD APPROACH

Shivani Patidar* and Shuchi Jain

ABSTRACT

The main objective of this study is to generate the sufficient data to evaluate the process validation by QbD approach. The study includes the validation of critical steps of manufacturing such as blending, compression and blister packing all process validation batches had been manufactured and validated in full compliance with cGMP requirement. The compression parameters of the three batches were with in the limits at the machine speed of 20 rpm – 40 rpm. The weight variation -427 % of the average weight. The observed hardness was in the range of 7.5 to 13.1 kp. The friability observed among the three batches was 0.18% w/w. The dissolution of the tablets was well. The dissolution profile of the three batches was comparable. The Uniformity of the tables throughout the compression run wasconsistent and with in the limit of Acceptance Value (NMT 15.0) with maximum 4.5. The coating parameter were within the limit. The dissolution of the tablets was well within the limit of predetermined specification. The profile of all three batches are comparable. Based on the results of the validation data, it shall be concluded that the manufacturing process as it consistently produces the product of predetermined quality parameters. Hence it can be concluded that the manufacturing process of Zidovudine 300 mg tablet was validated and was approved for routine production.

Keywords: Zidovudine, process validation, QbD approach, cGMP requirement, compression parameters, coating parameters.